MDStudy object

Yes

“Medical Devices” are defined pursuant to Art. 4 (1b) TPA as follows:
“…products, including instruments, apparatus, in vitro
diagnostics, software and other goods or substances which are intended to have or are presented as having a medical use and whose principal effect is not obtained with a medicinal product.”

Clinical Trial categories with MD pursuant to Art.20 KlinV/ClinO as of 01-01-2014:
- Cat A: Trials with medical devices bearing conformity marking and used in accordance with the instructions.
- Cat. C: Trials with medical devices not having a conformity marking and not used in accordance with the intended purposes recognised in the conformity assessment and specified in the instructions; or the use of the medical device is prohibited in Switzerland.

The website of KOFAM (Koordinationsstelle Forschung am Menschen) provides a tool for assessing the category of a trial. The EC (not Swissmedic!) is responsible to check if the category is correct.
KOFAM: http://www.kofam.ch/en/home/